Medtronic earns CE mark to use its drug-eluting balloon to help hemodialysis patients

The In.Pact Admiral drug-coated balloon in an artery--Courtesy of Medtronic

Medtronic ($MDT) just won CE-mark approval to use its In.Pact Admiral drug-eluting balloon to help maintain hemodialysis access in end-stage renal disease patients in Europe. The device was already indicated to treat diseased peripheral superficial and femoral arteries and popliteal arteries.

Its mechanism of action will be similar to that used against peripheral artery disease. It will help prevent restenosis by opening the artery like other angioplasty balloons, and will also coat the vessel wall with the antiproliferative agent paclitaxel. To do so, a new 40-centimeter shaft designed specifically for arteriovenous venous access will be made commercially available in Europe, the company says.

According to a release, more than 2.5 million end-stage renal disease patients are receiving hemodialysis to filter waste from the blood when the kidneys are not functioning properly.

"For patients with hemodialysis, maintaining AV access is their lifeline to receiving the care they need to filter waste from their system. In the past, when the access site became stenosed, the only option was the use of a standard percutaneous transluminal angioplasty (PTA), which can result in the need for repeat procedures," said Dr. Konstantinos Katsanos, of Guy's and St. Thomas' Hospital in London, in statement. "The In.Pact Admiral DEB (drug-eluting balloon), in my experience, provides a safe and more effective way of managing AV access by preventing vascular restenosis, improving patency of dialysis fistulas and grafts, and reducing the need of repeat PTA procedures."

The expanded indication should help accelerate sales of a device that the company officials love to tout during presentations. At the J.P. Morgan Healthcare Conference, CEO Omar Ishrak said he believes the $50 billion merger with Covidien will help accelerate sales of the In.Pact Admiral, as well as the Solitaire stent retriever to treat stroke.

Covidien developed the Solitaire, and divested the drug-eluting balloon from its pipeline to Spectranetics in order obtain regulatory clearance for the merger. The new Irish company's large peripheral sales force is an asset, and led Bard ($BCR) to pursue a distribution partnership with Boston Scientific ($BSX) centered around its competing Lutonix drug-eluting balloon.

Medtronic recently announced that it will build a €13 million ($14.3 million) facility in Galway, Ireland, to manufacture the In.Pact for global markets, including the U.S.

- read the release

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